Actively Recruiting
CorMatrix Cor TRICUSPID ECM Valve Replacement Study for Adults and Pediatric Patients
Led by Corvivo Cardiovascular, Inc. · Updated on 2025-09-02
92
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
C
Corvivo Cardiovascular, Inc.
Lead Sponsor
Y
Yale University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and performance of the Cor TRICUSPID ECM Valve, including the Cor PEDIATRIC Tricuspid ECM Valve, for replacing dysfunctional tricuspid heart valves in both adult and pediatric patients. The study focuses on whether the device can be implanted successfully and safely, and if it effectively manages tricuspid valve disease and dysfunction over a 12-month period. The study also considers that many patients may undergo additional heart valve procedures alongside the tricuspid valve replacement. Participants will receive surgical tricuspid valve replacement with one of the Cor TRICUSPID ECM Valve models, either SIS 1.0 or SIS 2.0, with separate groups for adults and pediatrics. The device is intended to serve as the physiological right-sided atrioventricular valve. The study is non-randomized and includes different arms based on age group and valve model. Follow-up evaluations occur at hospital discharge, 30 days, 6 months, 12 months, and then yearly for up to 5 years after surgery. Participants will undergo preoperative evaluations followed by the valve replacement surgery. Postoperative assessments include monitoring procedural success at 30 days and individual patient success at 6 and 12 months. Additional long-term monitoring will continue annually for up to 5 years to observe safety and effectiveness outcomes. Patient consent, adherence to follow-up schedules, and the ability to return for evaluations are part of the participation requirements.
CONDITIONS
Brief Title
CorMatrix Cor TRICUSPID ECM Valve Replacement - Pivotal Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has a regurgitant or absent tricuspid valve requiring surgical treatment, including those needing additional cardiac procedures
- Patient or authorized guardian understands the procedure and agrees to follow-up evaluations
- Patient or guardian is stable geographically or willing to return for study visits
- The Cor TRICUSPID ECM Valve will serve as the physiological right-sided atrioventricular valve
You will not qualify if you...
- Tricuspid annulus smaller than 10 mm, too small for valve placement
- Left ventricular ejection fraction less than 25%
- Mean pulmonary pressure 50 mmHg or higher, or pulmonary vascular resistance over 6 Woods Units
- Emergency cardiac procedure or cardiogenic shock
- Cardiac transplant recipient
- Recent acute transmural myocardial infarction within 7 days causing cardiogenic shock
- Single ventricle patients where valve would be systemic AV valve
- Primary coagulopathy or uncorrected platelet disorder, unless reversible by transfusions
- Significant liver disease with elevated enzymes more than 5 times normal
- Severe kidney dysfunction with creatinine over 4.0 mg/dL or low GFR
- Stroke within 30 days prior to enrollment
- Major progressive non-cardiac disease with life expectancy under one year
- Active cancer or undergoing cancer treatments
- Hematological disorders or bone marrow suppressant drug use
- Known sensitivity to porcine materials
- Contraindication to anticoagulation or antiplatelet therapy
- Pregnancy
- Enrollment in another investigational study affecting treatment without approval
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Hospital stay typical of cardiac valve replacement surgery
Participants undergo surgical replacement of the tricuspid valve with the Cor TRICUSPID ECM Valve and receive immediate post-operative care.
1 surgical procedure visit and several in-hospital post-operative visits
Duration - Up to 12 months after surgery
Participants are monitored for safety and effectiveness outcomes after surgery, including evaluations at 30 days, 6 months, and 12 months.
Visits at 30 days, 6 months, and 12 months post-surgery
Trial Site Locations
Total: 2 locations
1
St Francis Hospital
Indianapolis, Indiana, United States, 46237
Actively Recruiting
2
Columbia University Irving Medical Center/New York Presbyterian
New York, New York, United States, 10032
Actively Recruiting
Research Team
R
Robert G Matheny, MD
B
Brad Solberg, MBA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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